# FDA recall Z-1561-2026

> **Altruan GmbH** · Class II · device recall initiated 2025-12-19.

## Product

Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs.

## Reason for recall

Product not cleared by the FDA.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1561-2026
- **Recalling firm:** Altruan GmbH
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-12-19
- **Report date:** 2026-03-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Massing, N/A, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1561-2026

## Citation

> AI Analytics. FDA recall Z-1561-2026. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-1561-2026. Source: US FDA. Licensed CC0.

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